66 information-security-"https:"-"https:"-"https:"-"https:"-"https:" positions at Center for Drug Evaluation and Research (CDER)

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

. If a need to change the labeling is uncovered as a result of this research project, FDA has new and expedited procedures under OTC monograph reform to initiate an administrative order to make safety

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 4 days ago

their molecular complexity. This complexity arises from diverse chemical modifications aimed at enhancing the stability, efficacy, and safety of these products. Consequently, there is a pressing need to enhance

FDA Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

of novel PRO-based ER analyses of tolerability associated drug exposure related adverse events to inform standard ER analyses for safety and provide complementary tolerability data to improve dosage

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available in the Office of Translational Sciences (OTS) at the Center for Drug Evaluation and

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: The Office of New Drugs (OND) is responsible for assessing safety and

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

mentorship by experts in the field, which is a unique opportunity for new scientists. You will have the opportunity to align your interests with areas of research need to OSE (e.g., drug safety, substance use

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

extrapolating safety and efficacy data from adults to pediatrics. Mentor: The mentor for this opportunity is Suryatheja Ananthula (suryatheja.ananthula@fda.hhs.gov ). If you have questions about the nature

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

of creatinine effects based on drug exposure and transporter inhibition potency. Acquiring regulatory review skills for evaluating safety, in vitro and pharmacokinetic data in drug applications, including

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

for evaluating emerging technologies and translational safety assessment. Mentor: The mentor for this opportunity is Martha Garcia (martha.garcia@fda.hhs.gov ). If you have questions about the nature